Qtest™ 11
The one device that has DI number included 100 strips.
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (5), Zhejiang (2), Guangxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
Record
| Listed by | DFI Co., Ltd., South Korea |
|---|---|
| FDA product code | CDM |
| Device type | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1785 |
| Establishment | Manufacturer |
| Record published | 2018-12-21 |
| Record revised | 2022-11-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0994 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pro Advantage | National Distribution & Contracting Inc | 4 |
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 3 |
| Urine Reagent Strips | Urit Medical Electronic Co., Ltd. | 2 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 2 |
| Urine Analyzer | Urit Medical Electronic Co., Ltd. | 2 |
| Ricca Chemical Company® | Ricca Chemical Company LLC | 2 |
| Cybow 11 | DFI Co., Ltd. | 1 |
| Mission U120 Touch Urine Analyzer | Acon Laboratories, Inc. | 1 |
| Aution™ Sticks 10EA Test Strips | Arkray USA, Inc. | 1 |
| URiSCAN 10 SGL strip | YD Diagnostics | 1 |
| Areta 10 Parameters Urinalysis Reagent Strips （50 tests kit） | Easy Healthcare Corporation | 1 |
| Chemstrip 7 Test Strips | Roche Diagnostics Gmbh | 1 |
Showing 12 of 26. All products under Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.